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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00619255
Other study ID # 32685
Secondary ID 1 H34 MC08508-01
Status Completed
Phase N/A
First received February 6, 2008
Last updated February 16, 2018
Start date March 1, 2008
Est. completion date June 1, 2014

Study information

Verified date February 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent needs assessments suggest that difficulties exist in care coordination between emergency medical services (EMS) systems and primary care for injured adolescents with alcohol problems and post-traumatic stress disorder (PTSD). This project will implement, evaluate, and disseminate the adolescent trauma support service model program that aims to enhance coordination between EMS systems and primary care/community services.


Description:

Goal 1: To coordinate care from EMS systems to primary care for injured adolescents.

Objective 1: To increase rates of connection to primary care providers to 55% for model program adolescents, compared to an anticipated connection rate of 25% in adolescents assigned to standard care, by 2010.

Goal 2: To reduce alcohol consumption over the course of the year after injury.

Objective 2: To reduce rates of alcohol consumption by 25% in adolescents assigned to the model program, compared to adolescents assigned to the standard care, by 2010.

Goal 3: To reduce adolescent PTSD symptoms over the course of the year after injury.

Objective 3: To achieve statistically significant reductions in PTSD symptoms in model program patients, compared to adolescents assigned to standard care, by 2010.

Activities Undertaken to Meet Project Goals:

We propose to implement and evaluate an innovative model program, the adolescent trauma support service, that aims to improve the quality of care for injured adolescents with problematic alcohol use and high levels of PTSD symptoms by enhancing coordination of care between EMS systems and primary care and community services. All injured adolescents ages 12-18 presenting to the Harborview Medical Center with injuries so severe that they require inpatient admission and/or 24 hour observation in the emergency department, will be screened for alcohol use and PTSD. Adolescents who screen into the study will be randomly assigned to the adolescent trauma support service or standard care. Two trauma support specialists will meet each injured adolescent and available family members by the ED gurney or inpatient bedside in order to elicit and address each patient/family's unique constellation of post-injury concerns. Next, the adolescent trauma support specialist will help to coordinate care received within the EMS system with primary care providers. The trauma support specialists will also have the capacity to deliver evidence-based motivational interviewing interventions targeting reductions in adolescent alcohol use. The trauma support specialists will link patients and families to evidence-based PTSD treatment through primary care and community resources. Program evaluation will include a comparison of the outcomes of adolescents randomly assigned to the adolescent trauma support program with those of adolescents assigned to standard care. Adolescents in the model program and standard care will be compared on the presence or absence of post-injury primary care visits and reductions in alcohol use and PTSD symptoms over the course of the year after injury. Nationwide dissemination activities of program evaluation results will include the publication of manuscripts in peer reviewed journals and presentations at national meetings by members of the interdisciplinary collaborative group that includes pediatric, mental health and surgical providers.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 1, 2014
Est. primary completion date October 31, 2010
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- The investigators will screen all English speaking female and male adolescents ages 12-18, who present to Harborview Medical Center with injuries so severe that they require inpatient admission and/or > 24 hour observation in the emergency department.

- All dyads where both parents consent and adolescents assent to the study will be enrolled in the study and randomized.

Exclusion Criteria:

- Adolescents who have suffered head, spinal cord, or other severe injuries that prevent participation in the baseline interview will be excluded from the protocol.

- Patients who require immediate intervention (e.g., self-inflicted injury, active psychosis, mania, and victims of family abuse) will be excluded and referred to the Harborview Inpatient Psychiatric Consult Service.

- Patients who are currently incarcerated or are likely to face criminal charges will be excluded.

Study Design


Intervention

Behavioral:
Adolescent Trauma Support Program
The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury.

Locations

Country Name City State
United States Harborview Medical Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zatzick D, Russo J, Lord SP, Varley C, Wang J, Berliner L, Jurkovich G, Whiteside LK, O'Connor S, Rivara FP. Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adol — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients With High Levels of Adolescent PTSD Symptoms Patients with symptoms consistent with a diagnosis of PTSD on the UCLA PTSD Reaction Index were counted. The UCLA PTSD-RI can be used to create an algorithm consistent with a diagnosis of PTSD by rating 1 intrusive, 3 avoidant, and 2 arousal symptoms with a rating of moderate severity. The PTSD-RI is scored on a scale from 0 (none of the time) - 4 (most of the time) with a > = 2 "some of the time" denoting this cutoff for moderate severity. This algorithm was used to identify patients with high PTSD symptom levels consistent with a diagnosis of PTSD. Baseline (injury), then 2, 5, and 12 months post-injury
Secondary Number of Patients Who Self-reported Alcohol Consumption or Drug Use Any self-reported alcohol or drug use using one yes or no question Baseline (injury), and 2, 5, and 12 months post-injury
Secondary Percentage of Asolescents Linked to Primary Care During the Study Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury Up to12 months post-injury
Secondary Percentage of Adolescents Who Self-reported Weapon Carriage Self-reported carrying of knife, gun, club or other weapon by adolescent Baseline (injury), then 2, 5, and 12 months post-injury
Secondary Number of Patients Experiencing High-Level Depressive Symptoms The investigators used the Patient Health Questionnaire (PHQ-9) to identify symptoms consistent with a diagnosis of depression on the 9-item Patient Health Questionnaire depression screen. Scores range from 1 to 27 with higher scores representing worse outcomes. Baseline (injury), then 2, 5, and 12 months post-injury
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